NCT06546475Not yet recruitingPhase 4
A Pilot Trial of Tapering Antipsychotics for Patients in Remitted Psychosis Co-administering With N-Acetylcysteine
Tapering Antipsychotics in Patients With Remitted Psychosis: From Bedside to Bench Employing Animal Model and N-Acetylcysteine Study and Back to Bedside
Source: ClinicalTrials.gov · Last updated 9 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The investigators are going to observe if add-on of n-acetylcysteine (NAC) 1200 or 2400 mg/d during tapering of antipsychotics in patients with remitted psychosis can help to reduce the pre-requisite of stabilization to 3 months (compared to the 6 months prerequisite of a previous Guided Antipsychotic Reduction to Minimum Effective Dose (GARMED) trial,) smoothly, without increased risk of relapse or frequency of adverse events compared to the 2-year results of the GARMED trial
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 29 Jul 2024
- Start date
- 1 Aug 2024
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Schizophrenia
- NCT number
- NCT06546475
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 20
- From 1 Aug 2024 to the primary completion date, 31 Jul 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A change in dose of current antipsychotic medication in recent 3 months
- Concomitant use of mood stabilizers, such as lithium, valproic acid, or other anti-epileptic drugs
- Mental retardation known as IQ below 70 prior to the diagnosis of schizophrenia
Other illness
- Admission to the acute psychiatric unit during the past 6 months
- A history of pervasive mental disorder or bipolar disorder
- A medical condition with significant cognitive sequelae
- A history of substance dependence during the past 6 months
- A history of allergy to N-Acetylcysteine
Other
- A score of 5 or more on any of the 30 PANSS rating items at screening
- Currently in pregnancy or breastfeeding
- Patient with phenylketonuria ( because the Actein Effervescent Tablet 600 mg/tab contains aspartame)
Who the study is looking for
- Both male and female outpatients or patients at psychiatric daycare service
- Age 18-60 years old at the time of screening
- A diagnosis of schizophrenia, schizophreniform disorder, psychosis NOS, based on the DSM-5 criteria
- With a Positive and Negative Syndrome Scale (PANSS), score \< 3 in all 3 positive symptoms (P1: delusion, P2: conceptual disorganization, P3: hallucination) and 2 general symptoms (G9: unusual thought, G5: mannerism and posturing) for at least 3 months
- With a PANSS score \< 4 in all 3 negative symptoms (N1: blunted affect, N4: social withdrawal, N6: lack of spontaneity/flow in conversation) for at least 3 months
- Currently receiving antipsychotic treatment at a fixed dose for at least 3 months, including long-acting injectable antipsychotic
- No revised use of benzodiazepines, antidepressants, anticholinergics, or other concomitant medications during the past 3 months
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.